strive 4 five

8/3/2019 Strive 4 Five

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N A T I N A LV A IN ET R A EI D E L I N E

TRIVE~


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N A T I O N A LV A C C I N ES T O R A G EG U I D E L I N E SSTR IVE~5


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ISBN: 0 642 82750 8Publications Approval number: 3713 Commonwealth of Australia 2005This work is copyright. Apart from any use as permitted under theCopy rig ht A ct 1968, no part may be reproduced by any process withoutprior written permission from the Commonwealth. Requests andinquiries concerning reproduction and rights should be addressed tothe Commonwealth Copyright Administration, Attorney General'sDepartment, Robert Garran Offices, National Circuit, Canberra ACT2600 or posted at http://www.ag.gov.au/cca
http://www.ag.gov.au/ccahttp://www.ag.gov.au/cca


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ContentsGlossaryIntroductionWhat's new?Why are we concerned about vaccine storage management?What is the cold chain?How sensitive are vaccines to heat and cold?Basicprinciples of vaccine storage managementChecklist for vaccine storageRefrigerators for vaccine storage

Domestic refrigeratorsUse of domestic refrigerators for vaccine storage

Storing vaccinesUsing a domestic refrigerator for vaccine storage

Ordering vaccinesMaintenance of the vaccine refrigeratorDefrosting and cleaning the refrigerator

Further points to consider if using a domestic refrigeratorPurpose-built vaccine refrigerators

Advantages of having a purpose-built vaccine refrigeratorQuestions you ask yourselfHow to choose a purpose-built vaccine refrigeratorIssues to note

MonitorsThermometersHow to check the accuracy of your thermometerTemperature chart recording systemsData loggersCold chain monitors

Caring for your vaccines during immunisation sessionsInvolving people in cold chain

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Management of cold chain problemsPower failure

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Cold chain breachCoolers

Tips for using coolersHow to pack a coolerFreezing and conditioning ice packs and gel packsSpecialised vaccine cold boxPortable refrigerators

Appendix 1: Vaccine storage self auditAppendix 2: Common misconceptions about vaccine storage management 39Appendix 3: Case Study General Practice-modifYing a domestic refrigerator 41Appendix 4: How to identify and manage situations when things go wrong 44Appendix 5: Frost Free and Cyclic Defrost Refrigerators 47Appendix 6: Data LoggersReferencesUseful contact details

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AcknowledgmentsThe Department gratefully acknowledges the principal authors (Sandi Grant, AndrewLangley, Karen Peterson, Ann Kempe, Nan Miller, Vicki Bryant, Jennifer Morton), membersof the National Immunisation Committee and the many others who provided comment aspart of the development of the guidelines.Dr Neil Hearnden kindly provided an example from his own practice in the Case Study inAppendix 3.

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GlossaryAccuracy check A method used to ascertain the accuracy of a thermometer.

This becomes very important if there has been an episodewhen the refrigerator temperature has been outside therecommended range for storing vaccines (see p 22 for detailson 'How to check the accuracy of your thermometer').

Adverse vaccine storage event A situation when vaccine storage temperatures have goneoutside the recommended range of +2C to +8C (excludesexcursions up to + 12C, lasting no longer than 15 minutes,when stock taking or restocking). In this document an adversevaccine storage event is often referred to as a'cold chain breach:

Ambient temperature Temperature of the surrounding environment in which thevaccine refrigerator is operating. If there is no air conditioningthese temperatures may fluctuate during a day.

Cold chain breach Vaccine storage temperatures have been outside therecommended range of +2C to +8C (excludes excursionsup to + 12C, lasting no longer than 15 minutes, when stocktaking or restocking). In technical documents a cold chainbreach may be referred to as an 'adverse vaccine storage event:

Cold life The cold life is the longest time that the vaccine will be ableto be stored within the recommended temperature range in acooler or specialised cold box.

Cold mass A non-technical explanation for describing the presence ofmaterials (e.g. cooled water bottles) in a refrigerator that willhelp to maintain cold temperatures, for example, if the powerfails or the door has been opened.

Commercial coolant packs Commercial coolant products, commercial gel~packs and othernon-ice coolants.

Cooler This is a generic term used by department stores to describeBsky"/Willow type solid-walled insulated containers.

Cooling plate A component of amechanical refrigeration system. Thecooling plate is a vessel where high pressure liquid refrigerantvaporises to a gas. Refrigeration of an enclosed space (load) isachieved when liquid refrigerant withdraws heat energy fromthe load as it changes to a gas. Withdrawal of heat energy isbased on the principle of the latent heat of evaporation. Thecooling plate is also known as plate evaporator, load heatexchanger, cooling plate and cold plate. It is usually located onthe back wall, inside the refrigerator (see Figure 3 p 42).

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Data logger Temperature data loggers are small, electronic devices thatmeasure temperatures and keep a record of the results.

Freezing In this document 'freezing' refers to a situation where vaccinesexperience temperatures at or below OC. Vaccines maynot appear frozen but may have been damaged at thesetemperatures.

Gel packs Commercial coolant products, commercial gel~packs and othernon-ice coolants.

Lagging Lagging is the process of using specific materials (e.g. fluid ormetal) and thickness of materials for the temperature probeso they don't respond to short term fluctuations (e.g. when therefrigerator door is open). This gives a better indication of theactual temperature of the vaccine and prevents the alarm goingoff unnecessarily.

Outreach clinic An outreach clinic is defined as an immunisation session thatis conducted in another venue away from the main or 'homeimmunisation venue. This service would normally last a numberof hours and staff would then return to the 'home venue beforethe end of the day. An outreach clinic should not be confusedwith a mobile service which normally spans a number ofdays and includes travelling longer distances and providingimmunisation sessions in a number of different sites.

Purpose-built refrigerators Refrigerators designed and constructed for a particularpurpose e.g. vaccine storage.

Refrigeration Withdrawal of heat from a chamber to achieve temperatureslower than ambient temperatures.

Thermostat A device that adjusts the amount of heating and coolingproduced and/ or distributed by automatically responding tothe temperature in the environment.

For further reading see the Proceedings of the National Workshop on Vaccine StorageManagement: http://immunise.health.gov.au/ vaccinestorage.htm especially for'Fundamentals of Freezing' and'Technical Issues with Refrigerators:

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http://immunise.health.gov.au/http://immunise.health.gov.au/


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I N T R O D U C T I O NIf w e do n't pro tect our va ccines they w on 't pro tec t o ur comm unity !This document is aimed at Australian vaccination service providers as aconcise, practical, user-friendly guide to vaccine storage. Because of theAustralian context and evolution in technology, knowledge and vaccinesthere are differences to World Health Organization documents and theAustralian Immunisation Handbook 8th Edition 2003. This documentreplaces Keep it Cool (2nd Edition 2001).This document outlines the basic principles for safe vaccine management.The technology for vaccine storage is changing rapidly. If you arepurchasing equipment it is recommended that you thoroughly investigatethe item. The material in this document may help you with yourinvestigations. For further information contact your state or territoryhealth department.

W HAT 'S N EW ?+ It is recommended that vaccines are stored in a purpose-built

vaccine refrigerator.+ Bar refrigerators are not recommended for vaccine storage.+ Management of storing vaccines in a domestic refrigerator has

changed. Vaccines are at greater risk in domestic refrigerators.Therefore, modifications and a diligent management planare essential.

+ With rapidly changing technology in refrigeration it is not possibleto give generalised statements on management that apply to allrefrigerators. There are, however, general recommended guidelineson managing vaccines. It is crucial that you 'know your refrigerator:

+ Recommendation for workplace policies and procedures for vaccinemanagement.

+ Emphasis on all people involved in transporting, storing andadministering vaccines to be trained in vaccine management toensure the vaccine remains effective and potent.

+ Self-audits (at least 12 monthly) of refrigerators storing vaccine arerecommended.

+ Increased emphasis on timely reporting of refrigerator temperaturesoutside of + 2C to +8C to your state or territory health department.

+ Advice about frequency of recording vaccine storage temperaturehas changed.

+ Changes to guidelines on use of ice packs/gel packs and monitoringvaccines in coolers and cold boxes.

- fl If w e don't ;,p ro te c.t o urvaccinesth ey w on'tpro tec t our

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- . . . ,V accines m ust 'Ibe stored andtransportedwith in therecommendedtemperaturerange of +2Cto +8Cat a ll tim es.

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W hy are we concerned about vacc ines to ra ge mana gemen t?

L As health professionals we need to ensure people receive an effectivehealth product (i.e, a vaccine that has not been adversely affected byheat or cold).

2. It is important to carefully manage resources. Vaccines are expensive(privately purchased conjugate pneumococcal vaccine can cost up to$180) and can be in short supply.

3. It is professionally unacceptable as well as uncomfortable to be ina position where you have to inform people that they or their childmay have received ineffective vaccine and will require revaccination.Cold chain breaches can occur even in well-designed andwell-managed systems as a result of technical malfunctions but ifthere are good procedures in place, problems will be detected andeffectively managed before ineffective vaccine is used.

4. Efficient vaccine storage management is a good quality assurancemeasure of a vaccine service provider.

W hat is the co ld cha in?The cold chain is the system of transporting and storing vaccines withinthe safe temperature range of +2C to +8C.The cold chain begins from the time the vaccine is manufactured, movesthrough to the state or territory vaccine distribution centres and endswhen the vaccine is administered.

Vaccines must be stored and transported at all times within therecommended temperature range of +2C to +8C

H ow sensitive a re vacc ines to hea t and co ld?Vaccines are delicate biological substances that can become less effective ordestroyed if they are:

+ Frozen;+ Allowed to get too hot; and+ Exposed to direct sunlight or fluorescent light.


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Freezing of vaccine is the most common reason for vaccine damage andloss in Australia.In this document 'freezing' refers to a situation where vaccinesexperience temperatures at or below OC.Vaccines may not appearfrozen but may have been damaged at these temperatures. Most vaccinesare considered to be damaged at Oe.

For vaccines that are cold or Ireeze-sensitive, the loss of potency followingfreezing is immediate and these vaccines must not be administered.When vaccines are exposed to repeated episodes of heat the loss of vaccinepotency is cumulative and cannot be reversed.

Basic prin cip les o f va cc in esto ra ge m a na geme ntObjectiveKeep all vaccines in the range +2C to +8C:Strive for 51'as this gives agreater leeway for protection from temperature fluctuations.Process

+ Simple, routine processes need to be established. Processes shouldbe designed to be easily maintained.

+ Establish written protocols for your vaccination service (templatesmay be available from your state or territory health department orlocal Division of General Practice). Accreditation of your practicemay require a written protocol. Protocols need to include:

Monitoring and recording of the vaccine refrigerator according tothe recommendations in these guidelines.Ordering and receiving vaccines.

Rotating stock so that vaccines with the shortest expiry date areused first.How to calculate vaccine requirements taking into accountnational guidelines for safe storage.Storage of vaccines, diluents and ice packs/gel packs.Monitoring and adjusting of equipment e.g. data logger,thermometer, thermostat.Equipment maintenance: including changing of thermometerbatteries, checking the accuracy of the thermometer, defrostingand cleaning of the refrigerator.

- ,Most vaccines I Iare consider edto be damagedat OC .

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-'S trive for S!'as this givesa great erleew ay f orpro tectio n fromtemperaturefluctuation.

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-'Know yourrefrigerator'It's crucial forsafe vaccinemanagement.

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Action to take if the refrigerator temperature goes outside therecommended range (including what to do and how to prevent ithappening again).Communication channels with other staff handling vaccines(if there are any interventions taken to maintain the cold chaine.g. adjustment of the thermostat).Ongoing education of staff on vaccine management, includingorientation of new staff.How to manage a power failure.How to pack a cooler (e.g. Esky", Willow", Coleman T M ) andcondition the ice packs/gel packs.

+ The system and the vaccine storage records are reviewed at leastannually e.g. through an audit, self-audit, peer review system oraccreditation process.

+ Retain documentation of vaccine temperature recordings accordingto your state or territory health department policy or yourmedico-legal and statutory requirements.

Equ ipmen t+ Have a refrigerator that has the capacity to store your maximum

vaccine storage needs (including influenza season).+ Have reliable, regularly maintained/serviced equipment.+ All domestic refrigerators vary, therefore it's crucial for safe vaccine

management that you 'know your refrigerator':Where are the cold and warm areas in your refrigeratori'What are the temperature variations from top to bottom, frontto back and side to side?What happens to the refrigerator temperature in hot and coldweather, or if the air conditioning failsi'What happens if there is a lot of use or no use such as holidaysand weekends?

+ Ensure your thermometer measures temperatures in Celsius notFahrenheit (confusion does occurl).

+ Do a check on the accuracy of your thermometer at least every12 months using the process outlined in 'How to check the accuracyof your thermometer' (see p 22).

+ Change thermometer battery at least every 12 months or asindicated by the manufacturer.


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+ Have a temperature monitoring chart for each vaccine refrigerator.Check with your state or territory health department or your localdivision for details on how to obtain a supply.

+ Place a sticker on the refrigerator and power point-'VaccineRefrigerator: 'Do not turn off or disconnect:

+ To secure the power point you may consider installing a device orhaving your refrigerator 'wired in' so your refrigerator cannot beaccidentally unplugged.

+ Keep refrigerator door openings to a minimum.+ Do not store food and other goods in the refrigerator.+ A thermostat override device is no substitute for good refrigerator

management and should not be used.+ Check that any alterations to a refrigerator will not void your warranty.+ Data loggers are not essential but may be useful in mapping'cold spots'

in your refrigerator or investigating problems (see Appendix 6 p 49).People

+ All people handling vaccines need to receive education on how tomanage them so the vaccines remain safe and effective. This involvesall staff members whose roles may affect safe vaccine storage atany stage.

+ Have a trained, designated person responsible for vaccine storageand implementation of protocols.

+ Have a trained nominated backup person(s) available to relieve thedesignated person when required.

-Do no t sto refood and othergoods in therefrigerator.

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- 1I t is im po rta ntIth a t p eoplehand.lingvaccines

understand ther ea son beh indwhat they aredo in a ndwhl t eyare~

o in g it!n,~

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Che cklist fo r va ccin e sto ra geL Reliable and stable refrigerator with adequate capacity.2. Accurate and reliable temperature monitoring equipment.3. Written process for monitoring and recording temperatures.4. Temperature probe is placed appropriately.5. Education and information for everyone handling vaccines (ensure

this includes new staff and reception staff).6. Maintenance schedule for temperature monitoring equipment,

checking the accuracy of the thermometer and changing thebatteries.

7. Written process for dealing promptly with a cold chain breach(include identification, response procedures, documentation andrecording, prevention of recurrence).

8. Written process for ordering and rotating stock.9. Written process for receiving vaccine.10. Written process for managing a power failure (e.g. having an

alternative storage such as an Esky" with ice packs/gel packs).


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R E F R IG E R A T O R S F O R V A C C IN E S T O R A G E

IntroductionDomestic refrigerators are designed and built for food and drinkstorage-not for the special temperature needs of vaccines.They aredesigned to meet the temperature requirements of fresh and frozen foods,they generally do not have particularly accurate temperature controllingsystems, and can have significant temperature variation within the onecompartment.For vaccine storage, domestic refrigerators suffer from the followingdrawbacks:

+ Temperature varies significantly every time the door is opened.+ Temperature rises during defrosting cycle in cyclicdefrost and

frost-free refrigerators.+ Cabinet temperature is easily affected by ambient temperature.+ Temperature setting using a dial is crude and inaccurate (as there is

no digital indication of set temperature).For these reasons, domestic refrigerators are not recommended forvaccine storage.However, if the only alternative is to use a domestic refrigerator for vaccinestorage, the following information is provided.

Domes t ic r efr ige ra to r sModification of domestic refrigerators is necessary to reduce the risk ofadverse vaccine storage events.There are various types of domestic refrigerators on the market. All typeshave some positive and negative features that will need to be consideredwhen using a refrigerator to store vaccines.Cyclic defrost (see p 48) and bar refrigerators are not recommendedbecause they produce wide fluctuations in the internal temperatures, withregular internal heating.Frost-free refrigerators (see p 47) do not have heating cyclesbut have lowlevelwarming cycles.They usually have several temperature zones to meetthe requirements of different foods. In these refrigerators, the top shelf isnot necessarily the coldest part of the unit.Bar refrigerators, in particular, are strongly not recommended becauseof the risk of freezing, temperature instability and susceptibility to ambienttemperatures.

-Domesticrefrigeratorsare notrecommendedfor vaccinestorage.

-Modificationo f domest ic~efrigerators1 S necessaryto reduce therisk of adversev ac cin e s to ra geevents.

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- Barrefrigeratorsa re unsuit ab lefor storingvaccines andshould notbe used!II

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-Domestic r" lrefrigerators Iia re unsuita bl efor vaccine

stor~ge i f t~ evaccme serviceprovider doesnot haveappropriatev ac cine sto ra geprocedures thata re d il igent lyundertaken.

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Domestic refrigerators generally have two compartments:+ A main compartment ('the refrigerator') for storing vaccines and

diluents, in which the temperature should be kept between +2Cand +8C. The thermostat is used to adjust the temperature.

+ A second compartment ('the freezer') for freezing ice packs/gelpacks. If the refrigerator is working properly, this section will beapproximately -18C.

Refrigerators have different capacities for storing vaccines and for freezingand storing ice packs/gel packs. A refrigerator in a health facility should beable to hold:

+ A one-month supply of vaccines and diluents in the refrigeratorcompartment.

+ Have a reserve stock of vaccines and diluents (an additional 25% to50% of a one-month supply). This will depend on whether you arein a remote location and your state or territory policy. Contact yourstate or territory health department for details.

+ Frozen ice packs/gel packs in the freezer compartment (will assist instabilising the temperature in your refrigerator compartment).

+ Bottles of water or unfrozen ice packs/gel packs in the refrigerator(to act as a buffer to freezing and warming e.g. if there is a powerfailure) (see Figure 1 p 17).

Domestic refrigerators are unsuitable for vaccine storage if the vaccineservice provider does not have appropriate vaccine storage proceduresthat are diligently undertaken to ensure that vaccines are stored safely.


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Use of dom estic re fr igera to rs fo rv accin e s to rageS t or in g v ac ci n e sIt is possible (although complex) to manage domestic refrigerators toreduce the risk to vaccines.If you already have an existing vaccine refrigerator in use the followingcriteria should be met:

+ The refrigerator is used exclusively for the storage of vaccines.+ The refrigerator maintains temperatures without fluctuating into the

danger zones (< + 2C, > +8C).+ The refrigerator is reliable and has not required repairs over the last

two years.+ The refrigerator is free of any water or coolant leaks.+ The refrigerator compressor is quiet (a noisy or audible compressor

may require attention).+ The seals are in good condition and are sealing tightly.+ The door of the refrigerator closes properly (ensure you comply with

the manufacturer's directions about the refrigerator being level).+ The refrigerator is an adequate size for the clinic! practice storage needs.+ Staff have relevant knowledge about storing vaccines which is

detailed in a written protocol.If you cannot meet all these criteria you should consider a replacementpurpose-built vaccine refrigerator.

U sing your dom estic re frigera to r fo rv accin e s to rageStep 1:Ensure the refrigerator is placed out of direct sunlight and themanufacturer's instructions for air circulation around the back and sidesare followed. Be aware of seasonal changes in the room temperaturethat may affect the temperature of the refrigerator. Ensure the vaccinerefrigerator is in a secure area accessible to staff only.

-I t is po ssib le(althoughcomplex)to m an agedomesticre fr ig era to rs toreduce the riskto vacc ines .

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- . . . ,Do n ot storefood and othergoods in therefrigerator.

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-Consider areplacementpury.ose~builtrejrigerator.1

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Step 1:P la ce therefrigeratorout O J directsunlight.

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Step 2:Mark thepow er sou rc eclea rly so ther efrig er ato r isnot unp lugg edor turned offaccidentally.

-Step 3:P la ce waterbottles or icepacks/gelpacks in yourJ freezer.

Step 4:F ill the low erdraw ers andthe doorw ith p la sticwa te r bot tle s/containers.

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Rationale:Some refrigerators need to have clearance at the sides and back to preventheat build up. Manufacturers usually provide recommendations regardingthe clearance required. Placing the refrigerator in direct sunlight or nearheat sources (e.g. a hot water service or warm external wall) increasesthe potential for higher temperatures and requires the refrigerator towork harder. The vaccine refrigerator should be placed in a secure area tominimise the risk of unnecessary door opening, power being switched offat the power point and tampering with stock.Step 2:Ensure the power source is marked clearly in a way to prevent therefrigerator from being accidentally unplugged or turned off.

Rationale:Accidental disconnection from the power source can cause heat damageto vaccines, particularly if unnoticed for a long period. The power sourcecan be protected by placing a sticker (such as the sticker below) abovethe power plug and switch. The refrigerator can also be 'wired in' so thatthere is no switch, or a lockable switch. Check your hardware store for theavailability of devices to prevent unplugging or turning off the refrigeratorat the power point.

DONOTTurn off or

disconnect thisrefrigerator

Step 3:Place water bottles or ice packs/gel packs in your freezer.

Rationale:This will assist in stabilising the temperature in your refrigeratorcompartment as in most frost-free refrigerators cold air is distributed fromthe freezer to the fresh food compartment. This will also help to stabilisefreezer temperatures and on-off" cycling of the refrigerator as well as beingavailable for vaccine transport.Step 4:Fill the lower drawers and the door with plastic bottles/ containers filledwith water. Leave a small space between the bottles/ containers. If you arenot storing many vaccines you can help maintain temperature stability byplacing cooled water bottles on unused shelves.


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Rationale:Domestic refrigerators often present a risk to vaccines due to the 'cold' spots.Using cooled water bottles will help stabilise the temperature by increasingthe 'cold mass'-that is, it keeps the temperature inside the refrigerator morestable and reduces warming periods when the refrigerator is opened. It isparticularly useful if there is a power cut or other cause of refrigerator failure.

+ Salt water may be used to make the water undrinkable (add about1-2 tablespoons per litre). This prevents people drinking the waterand leaving the bottles empty, affecting the 'cold mass: Label thebottles 'contains salt water:

It is important not to judge whether freezing of vaccines has occurred byobserving the physical appearance of the vaccines or the water bottles. Evenif the water bottles are unfrozen this is not an indication that temperatureshave not reached oe .Step 5:Know your vaccine refrigerator by recording temperatures throughout therefrigerator. The key areas to monitor are on each shelf from top to bottom,front to back and side to side. The recording device (data logger/thermometerprobe) needs to be left in each position for a minimum of 24 hours. Thecoldest area is often near a cold air outlet or the cooling plate.Rationale:In some refrigerators the coldest area is the top shelf or the front of thebottom shelf. However this is not necessarily true of all refrigerators as allmodels differ-even those from the same manufacturer. The coldest area isoften near a cold air outlet or the cooling plate.It is important that 'cold spots' are identified by detailed monitoringthroughout the refrigerator. This can be done by placing data loggers (seeAppendix 6 p 49 for information on data loggers) or temperature probe(s)in all areas of the refrigerator noting the different temperatures beforecommencing vaccine storage. The minimum time for monitoring in eachposition is 24 hours. This will capture all the fluctuations that occur indomestic refrigerators. Depending on the type and number of monitorsyou have access to, comprehensive monitoring of your refrigerator may takesome time to complete. While assessing the 'cold spots: it is recommendedto use some type ofcold mass' to imitate a batch of vaccine (e.g. cooledwater bottles) as refrigerators behave differently when empty. Your stateor territory health department or local division of general practice may beable to assist with logging your refrigerator.You need to be aware of how to manage a refrigerator effectively i.e, wherethe air vents are (see p 47), and how to adjust the thermostat.

-Frozen orda'?1agedvaccme mayn ot a pp ea rsolia orchanged inJ appearance.~~iiiiiiiI

- ~ Itep 5:'Know_yourvaccmere fr ig era to r' b ym onitoring a ndre co rd in g th etemperaturesthro ugh out therefrigerator.J ' ~ " = = = - - - ~ : : : : ~ . . . . . . _ ! ! 1

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St~ 6:Modi y andstabi ise thetemperatureo f th e va ccinerifrigeratorbe fore stock ingw ith v ac cin e.

Step 7:S to re v ac cin esin th eirorigin~lpackagtngin labelled,enclosed plasti ccontainers.

- ,Vac cin es mus t [ Inever be s to redin the door ofthe ref rigera tor .

J~~~I-St~ring.va ccines int he ir orig ina lpackaging, inenclosea plasti c

containers,h elp s to p ro tec tth em J romtemperatureL . . fluctuations.

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Step 6:Modify and stabilise the temperature of the vaccine refrigerator beforestocking with vaccine.Rationale:The refrigerator temperature needs to be stabilised before using for vaccinestorage. This will minimise the effect of temperature variations on vaccine.Step 7:Store the vaccines in enclosed plastic containers, in their original packaging(e.g. Tupperware, Decor,Willow or enclosed drawer). Label containersclearly with name(s) of vaccine(s).Do not crowd the vaccines by overfilling the shelves. Allow space betweencontainers for air circulation. Have a protective barrier (e.g. polystyrenestrip/unfrozen ice pack/gel pack) for each container (seeRationale').Ensure a gap of at least 4cm from all refrigerator walls, including theback. If using tightly sealed enclosed plastic containers (e.g. Tupperware,Decor,Willow) you will need to create an opening or gap to avoiddamage to the temperature probe cord. Alternatively store vaccine with thetemperature probe in enclosed plastic drawers where there is no pressureon the cord. Vaccines must never be stored in the door of the refrigerator.Rationale:Storage of vaccines in labelled enclosed plastic containers allows easyidentification of vaccines and minimises the time spent with the dooropened searching for vaccines. Time spent searching can also be reduced byhaving a basic map of vaccine locations on the outside of the refrigeratordoor so people can go 'straight' to the vaccine when the door is opened.Enclosed plastic containers will help to stabilise temperatures a little andprovide some protection in borderline freezing episodes as well as againsteffects from the cooling plate and blasts of cold air from outlets. A buffersuch as a small unfrozen ice pack/gel pack will add 'cold mass' and thereforeminimise temperature fluctuations when the container is opened to accessvaccines. There are two approaches that can be used:

+ A polystyrene strip (e.g. 12-20mm thick) glued to the inside oroutside of each container, on the side which is facing the coolingplate/ condenser / cold air outlet. This will provide further protectionfor vaccines.

+ An unfrozen ice pack/gel pack can be placed on edge to be abarrier inside the container. This will have the further advantageof providing 'cold mass' within the container to help stabilisetemperatures.


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Both of these approaches can be combined if you are storing a smallquantity of vaccine and/or you have unstable refrigerator temperatures.Air circulation between enclosed plastic containers is necessary to maintaina more constant ambient temperature.Storage of vaccine against refrigerator walls increases the risk of freezing.It is necessary to ensure a space between enclosed plastic containers andthe cooling plate. The same applies in refrigerators where streams of coldair are used to lower temperatures (typically in Irost-Iree models); vaccinesnear any air vent (which can often be a duct at the rear or from overhead)are at risk of freezing. Therefore a barrier may protect these vaccines also.

Overstocking of vaccine will place all vaccines at risk as cold aircirculation will be impeded and consistent, stable temperatures

throughout the refrigerator will be difficult to achieve.Step 8:Place Ireeze-tolerant vaccines in the shelves identified asbeing the coldestand Ireeze-sensitive vaccines on shelves identified as having more stabletemperatures (e.g.no 'cold spots). Knowing this will depend on identificationof the coldest areas in your vaccine refrigerator (see Step 5 p 11).

Rationale:Measles, Mumps, Rubella, OPV and Tuberculosis (BCG) vaccine will notbe affected by temperatures less than oe . Freeze-sensitive vaccines (DTPacontaining vaccines; Hib, Pneumococcal, Influenza, Hepatitis, Polio(inactivated-IPV) and some Varicella vaccines) are better placed on theshelves where the temperature is more stable. The lower drawers and thedoor get too warm for safe vaccine storage and are best used to store cooledwater bottles to provide 'cold mass' to stabilise temperatures.Step 9:Ensure that each domestic refrigerator storing vaccine has a Celsius digitalminimum/ maximum thermometer and a temperature recording chart.

Rationale:A recording chart is required to document minimum and maximumtemperatures. This written record enables staff to monitor and take actionif temperatures go outside the recommended range. Check with your stateor territory health department or your local division for details on how toobtain a supply.Note: Thermometers need to be accurate-check the accuracy and

change the battery at least every 12 months or as specified bythe manufacturer (see'How to check the accuracy of your

thermometer' p 22).

- -,S afe sto ra ge Icapacity w illb e re du cedwhen usingenc lo sed p la sticcontainers. Is

y our r ef rig erato rbig enough foryour needs?I- _-

Do notoverstock yourrefrigeratorw ith v accin es.

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Step 8:Place freeze~sens it ive vacc ineson she lvesw ith sta bletemperatures.Place freeze~tolerant vacc ineson she lvesid en tif ie d a sbeing th e coldes t.

Step 9: t ~I t is essen tia l th ateach domest icrefrigeratorstoring I Ivaccine has aCels ius d ig it alminimum/maxtmumthermometerand atemperaturerecording chart .

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-Thermometersneed to beaccurate.

Check theaccuracy andchange thebattery atlea st e very 12months or asspecified by theman u factur er .

Step 10:P lace the digitalminimum/maximumthermometerprobe inside avaccine box in aco nta in er s to rin gfreeze~s~nsitivevaccmes.

-Step 11: Checkand recordtemperaturesat least daily,before thevaccine is used.

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r t I S tep 1 0:

The thermometer probe should be placed:+ inside vaccine packaging (box and leaflet) once a vial has been used;+ inside and near the back of an enclosed plastic container (storing

Ireeze-sensitive vaccines); and+ avoid putting this container in the coldest part of the refrigerator.

Rationale:Placing the thermometer probe inside vaccine packaging (the box andleaflet) allows the probe to measure the air temperature closest to wherea vaccine vial would be and simulates vaccine temperature. The box andleaflet (product information) provide some further protection from veryshort term fluctuations e.g. after the door is opened and closed. An emptybox with the product information is used so that the probe does not getmisplaced when vials are used. Label the box as 'empty' so the probe won'tbe inadvertently moved.S tep 1 1:Check and record minimum/ maximum temperatures at least daily, beforethe vaccine is used.

Rationale:Daily temperature recording is a minimum requirement but it is highlydesirable to check refrigerator temperatures twice daily (at the beginningand end of each day). Checking and recording the temperatures beforeusing vaccine enables the identification of problems before vaccine (whichmay be damaged) is given. Twice daily temperature checks will giveyou a better indication of any problems in your refrigerator's functionand temperature fluctuations over the course of the day.However, thetemperature needs to be viewed and considered every time the refrigeratoris opened. The temperature needs to be read and recorded:

+ on receipt of vaccines;+ every day before vaccination commences (and, ideally at the end of

the working day);+ last thing Friday afternoon and first thing Monday, if the centre

closes over the weekend; and+ during outreach clinics the minimum/ maximum temperature should

be monitored hourly.It is assumed that many clinics/practices don't operate seven days a week:temperature recording does not need to be done on the days the practice isclosed providing the minimum/ maximum temperatures are monitored andrecorded before commencing vaccination.


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S tep 1 2:Keep the door closed as much as possible. Vaccine refrigerators shouldhave a sticker to remind staff to keep door opening to a minimum.

Rationale:Reducing door opening helps to keep internal temperatures stable.

S tep 1 3:Ensure that one person is responsible for adjusting refrigerator controls butthat all staff are appropriately trained to ensure continuous monitoring.

Rationale:There should be one key person in each facility who is responsible for coldchain management to enable consistency. However other relevant staffshould be trained to ensure that continuous monitoring is maintained. Allclinics/ practices should have documented protocols and procedures andregular education or training sessions to ensure staff awareness.S tep 1 4:Establish and document protocols for response to cold chain breaches.

Rationale:In order to ensure that effective vaccine is administered it is importantto promptly identify and manage cold chain breaches. This will minimisethe risk of ineffective vaccine being administered, resulting in recall forrevaccination. All staff need to be aware of these protocols.S tep 1 5:A vaccine storage self-audit should be undertaken by the clinic/practiceat least every twelve months. Perform it more frequently if you areexperiencing cold chain problems (see'Vaccine Storage Self Audit tool'Appendix 1 p 36- 38).Rationale:It is important to self-audit your vaccine refrigerator as part of a routinequality assurance and risk management process. It also enables you to haveconfidence that you are administering safe and effective vaccines.

Step 12:Keeprefrigeratordoo r openingsto a m inim um .

-Step 13:Only onep erso n sh ou ld"beresp.ons!ble

for aaJus ttngthe refrigera torcontrols. I I

Step 14:Establishp ro to co ls f orc old ch ainbreaches.

Step 15:Complete av ac cin e s to ra geaudit at leastevery 12months.

lS


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- . . . ,Rotate stock sov ac cin es w ithth e sho rte stexpiry date are

j used f irs t. !

-E nsure yourr ef rig er ato r isin good w orkingorder.

16

Ord er in g vacc in eKeep vaccine stock to a minimum by regularly ordering only the quantityof vaccine required for the period until the next delivery. Rotate stock sovaccines with the shortest expiry date are used first.The following formula can be applied when ordering vaccines for aclinic/ practice.

Quantity required (i.e, quantity used in last period) minus the amountleft over from last period plus 10% of quantity used in the last period(buffer or reserve stock). Contact your relevant state or territory vaccinedistribution centre about its policy for ordering vaccines before usingthis formula.Example:30 OTPa (quantity used last period) minus 5 OTPa (amount still inthe refrigerator) plus 3 OTPa (10% of quantity used in the last period).Quantity required is 28 OTPa.

I M ain te na nc e o f th e va cc in e re frig era to r+ Report breakdowns immediately and arrange for alternative

monitored storage for vaccines while the refrigerator is repaired.+ Regularly check the refrigerator seals to ensure a good seal ismaintained. Replace the seals if they are damaged or cold air is

leaking from the refrigerator.+ Defrost refrigerator regularly, if required, to prevent build-up of ice

which will result in unstable temperatures. Regular defrosting alsoaids in the efficient functioning of your refrigerator.

+ If there are exposed coils on the back of the refrigerator keep themclean and dust free to improve operating efficiency.


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Defr os tin g o r c le an in gWhen defrosting or cleaning the refrigerator, move the vaccines to a secondrefrigerator (which must be monitored during this time). Alternatively,store and monitor the vaccines in a cooler (see cooler section on p 28- 30for packing guidelines).

~p li'(i~er 'A l! ! ~ ~ th !~ p.~~"'iililP~~J:(Iii' oot~f i l1(Ir w , f i ' ! : t i ' ,' i F . a ~ care'oot t ! J < b'l!xt.the fr,~rr co'idiailrout le t ! ;

,I ce p ad k5 fg e l p ad ks c an be , S~iJedIn th e d O @ r ~ : i h e 1 ~ '

ke p;E~~1 ~~!13 ilIlid Ib~~Q f wiiiEr g. r ~I~:~~

FtII '~heel i ilpt) ' ~pace olil dled oo r i3 liid~Ii.Ile ~ dr,;w.'l!I~,wH h~~~I'es o(jh'iMl~r~li: w~~ '~r '~'fI'~p thll;~~'g\[email protected]~iIe~~y.,

Figure 1: Modification of a domestic refrigerator

Furthe r po in ts to cons ider if us ing adomes tic r efrig e ra to rPurpose-built refrigerators are recommended for safe storage of vaccine.Bar refrigerators are unsuitable and should not be used to store vaccine.1. The refrigerator (see p 47 -48)

+ The refrigerator needs to have a separate freezing compartment.+ Vaccines need to be protected from cold air blasts in refrigerators

that have cold air outlets such as frost-free refrigerators.+ Vaccines need to be protected from the cooling plate (usually on the

inside back wall) if you have a cyclic defrost refrigerator.

- ,Bar

' Irefrigeratorsare unsui tablefor sto rin gv ac cin es a ndshould not bej used.. '" =

1 7


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- r Warning

IRefrigeratortemperaturesfluctuateseaso, ,!al ly andvaccines canb e a t inc rea sedr is k o f f re ez ing,especiallyduring coldsnaps.. n

.~

1 8

+ The refrigerator needs to have the capacity required to store vaccinessafely,including busy times such as pre-winter influenza programs.Using enclosed plastic containers will reduce the storage capacity.

+ If outreach clinics are conducted the refrigerator needs to have afreezer big enough to freeze sufficient ice packs/gel packs.

+ Consider back up service including costs of delivery, maintenanceand repairs.

+ If you plan to modify your refrigerator to ensure safety for vaccinestorage, check this will not affect the warranty.

+ Consider energy efficiency.

2. Placement of the vaccinerefrigerator+ Avoid placing the refrigerator against an outside wall, which can be

subject to hot and cold temperatures as the weather changes.+ The room ideally needs to be insulated if there are extremes of room

temperatures.+ Many refrigerators become warmer in hotter weather and colder

in cooler weather but some refrigerators become colder in hotterweather and warmer in cooler weather. If there are wide fluctuationsin climatic conditions an air conditioning system is important. Beaware of what happens when the air conditioning is turned offovernight, and on weekends and holidays.

+ Ensure sufficient ventilation space around the refrigerator.

3. Power source reliability+ Consider the use of a back-up generator if there are regular power

blackouts or interruption to supply.+ Consider alarming the refrigerator.+ Make sure the refrigerator cannot be inadvertently unplugged

(see Step 2 p 10).

4. Training+ Ensure education and training for those who monitor the

refrigerator and manage the vaccines.+ Where people performing maintenance on refrigerators storing

vaccines are employed in your organisation, ensure they receiveeducation and training.


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P U R P O S E -B U IL T V A C C IN E R E F R IG E R A T O R SThe main features of purpose-built vaccine refrigerators are:

+ A stable, uniform, and controlled cabinet temperature unaffected byambient temperature.

+ Defrost cycleallowing defrosting without rises in cabinet temperature.+ Standard alarm and safety features alert and/ or prevent irregular

temperature fluctuations in cabinet.

A dvan tag es of ha vin g a purpo se-builtvacc ine re fr ige ra tor

+ Management of a purpose-built refrigerator is less demanding than adomestic refrigerator.

+ After programming, all temperatures within the refrigerator aremaintained in the +2C to +8C range. This minimises the risk ofvaccines being stored outside the recommended temperature range.

+ Good temperature recovery e.g.when the refrigerator has beenopened to access vaccines.

+ Nearly all of the internal space can be used for storing vaccines(check with the manufacturer about how to pack the maximumamount of vaccine and suitability of storing vaccines on the floorof the refrigerator). Therefore, the size of the purpose-built vaccinerefrigerator may be smaller than your previous domestic refrigerator.

+ Storage of other temperature sensitive medical products e.g.pharmaceuticals stored between +2C to +8C is acceptable in avaccine storage refrigerator.

The following points should be considered when purchasing apurpose-built vaccine refrigerator.

Questio ns to ask yo urse lf+ How big does my refrigerator need to bei' What is the maximum

amount of vaccine I need to store, particularly during specialprograms such as the influenza programi'+ Do I have the space in my clinic/practice for this size refrigeratori'+ If the service does outreach clinics, do I need to consider ice pack/gel

pack freezing capacityi'+ If I do not buy a purpose-built vaccine refrigerator what are the risks

to my clients and what is my legal risk?+ Where will the refrigerator be placed? If it is against an outside wall

it may be hotter in summer and potentially affect the performance ofthe equipment.

- , _=r: !o apurpose~builtrefrierator isless em andingthan adomesticJ refrigerator.

~

-In a r < ~ !puy:?se~builtre r ltera tornear y all ofthe in te rnalspace can beused for . s to ring

v ac cmes .

19


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-Is it re~llya va ccm erefrigerator?

-W ill it deliverwhat youexpect?A sk q ues tio ns !

2 0

,

H ow to choose a purpose-bu ilt vacc inerefr igeratorSome parts of the section 'Further points to consider if using a domesticrefrigerator' (seep 17) will be relevant.Also consider:

Capacity for having an alarm system. Alarm systems have variousoptions e.g.capacity to notify someone remotely, by automatictelephone dialing, or a central area that is staffed 24 hours a day.Choose the alarm system which best suits your needs.Does it have a'door left open' alarmi'The temperature recording system may be visual, or chart form.Ensure the temperature can be easily read and accessed e.g. somerefrigerators have the chart recording system placed at the bottomof the refrigerator.

4 . Does it have an easy to use minimum/ maximum temperaturedisplay featurei'

5 . Does the temperature probe have appropriate temperature lagging(see glossary) device?

6 . Does it need enhancements (e.g. alarms, temperature monitoringfeatures) and what do these cost?

7 . If purchasing enhancements ensure they are easy to use.8 . Warranty: What are the conditions and durationi' Will

modifications to the refrigerator void the warranty?Back up support and servicing varies from company to company.Determine availability and cost.

9 .

10. Does the supplier/manufacturer have quality assurance processes?1L What size space do you have for the refrigeratori'12. Can the refrigerator record how long the unit has been

without poweri'13. How long will it stay within the recommended temperature range

if there's a power failure (do you need to add 'cold mass' e.g. cooledwater bottles) i'


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Issues to no te+ Even though there is more usable space it is important not to

overstock your purpose-built vaccine refrigerator. You need todiscuss the usual and maximum level of stock you can hold in yourpurpose-built vaccine refrigerator with the manufacturer. Your stateor territory health department may be able to help you calculateyour maximum storage needs.

+ If you are storing very small amounts of vaccine in a purpose-builtvaccine refrigerator check with the manufacturer if you need to addmore 'coldmass' (i.e, cooled water bottles) to the refrigerator.

+ The placement of the purpose-built vaccine refrigerator in theclinic/practice is very important, refer to the refrigerator companyfor advice.The space around the purpose-built vaccine refrigeratoris determined by the manufacturer's recommendations and must beapplied during installation.

+ Vaccines can be stored in shallow plastic baskets/trays clearlylabelled with the name(s) of vaccine(s). It is not necessary to useenclosed plastic containers as the purpose-built vaccine refrigeratorhas constant temperature control. Do not crowd the vaccines byoverfilling the shelves.Allow space between baskets/trays for aircirculation.

+ Cool the vaccine refrigerator before stocking with vaccine.+ Even with vaccine purpose-built refrigerators, temperatures need to

be monitored and recorded at least daily, before vaccine is used(see Step 11 page 14).

+ If you have any concerns setting up your new purpose-built vaccinerefrigerator contact the service technician.

+ Depending on the quality and design of your purpose-built vaccinerefrigerator, it may warm quickly during a power failure. Always havean alternative means of vaccine storage available.

+ Purpose-built refrigerators with glass doors may not have ultraviolet(UV) filtering. This is another reason why vaccines must be storedin their original packaging to protect them from the light.

Your state or territory health department, Public Health Unit or Divisionof General Practice may have a list of current purpose-built vaccinerefrigerator suppliers in your state or territory.

- r " J .Delendingon t equalityand design ofy ou r p urp ose~built v accinerefrigerator,it may warmquic kly d urin ga p ower

~ failure.= d

- ,Be aware of

:!i gh t sensi ti vev ac cin es (mostvaccines aresensitive to anyform ofUVl igh t, includingfluorescent

l light).~ ~~I

21


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- r ' J .A m inim um /!maximumthermometeris a n essentialreq uirem ent fo rtemperaturemonitor ing.

-Check theaccuracyo f yo urthermometerand change thebattery a t leastevery

12 months.~!~~~~1If ~

22

M O N I T O R S

Thermomete rsA minimum/ maximum digital thermometer is an essential requirement fortemperature monitoring. The most common types used for refrigeratorsare dial and digital. The minimum/maximum thermometer must be resetregularly (i.e, at least daily, on work days) for meaningful temperaturerecording. Ensure you choose a thermometer that reads Celsius. Differentmodels of minimum/ maximum thermometers may vary in accuracy.They also require annual checks to ensure accurate measurement, as flatbatteries or a damaged probe or cable can affect readings. You can checkthe accuracy of a minimum/ maximum thermometer by performing thefollowing steps:

'H o w to chec k the a ccu ra cy o f y our therm ome te r'1. Twe-thirds fill a polystyrene or plastic cup with cold water. Place

cup in the refrigerator freezer until a fine layer of ice forms onthe top and small sections of ice form within the fluid (this maytake up to 21h hours). Using this method the mixture is OC ifice is present. Place the temperature probe into the middle of thecontainer (be careful not to let the probe touch the container).

2. Observe the temperature on the display screen at 2 minutes.Rationale:The temperature will drop quickly at first and then more slowly. Thetemperature should drop to OC within 2 minutes.An 'acceptable' degree of accuracy of a thermometer can vary e.g. towithin 1C. Even if your thermometer is considered 'accurate' thischeck could result in the display screen showing three possible readings:+ 1C, OC, -1C. Record the results of the accuracy check on yourtemperature chart. This information becomes important, particularlyif the vaccine refrigerator temperature goes outside the recommendedrange of +2C to +8C. Check with the organisation who supplies yourthermometer about the expected degree of accuracy.The thermometer needs to be accurate to 1C or better. If yourtemperature reading is more than one degree above or below OC attwo minutes replace the battery and test again. If still not within rangereplace the thermometer.A check of the accuracy of your thermometer is recommended after thebattery is changed and at least every 12 months for auditing purposes,or if you are having cold chain problems.


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T em pera ture C hart R ecord ing S y stem sTemperature chart recording systems can record temperatures over along period of time as well as providing visual and audio alarms. Theycan be set to record air and/ or product temperature. These systems canbe installed in refrigerator units but check with the manufacturer as thismay void your warranty.

Data lo gg ersData loggers can be used in audits and to enable you to 'know yourrefrigerator' by recording patterns of temperatures over time. Loggersuse a similar measuring principle to chart recorders but record the dataelectronically. The data can be stored by the monitoring system and canbe downloaded. Daily minimum/ maximum temperatures still need tobe manually recorded as a timely alert to any breach in the cold chain.If using a data logger for routine temperature monitoring (i.e, insteadof a minimum/ maximum thermometer) it must have a visual display ofminimum/ maximum temperatures to allow daily real time recordings to beread (see Appendix 6 for further information on data loggers).

Cold c ha in mon ito rsCold chain monitors (CCMs) should accompany all vaccines duringtransport. If CCMs are placed with vaccine deliveries, they should bechecked for colour change and the temperature recorded when the vaccineorder arrives at the clinic.Dual time-temperature indicators are a type of cold chain monitor andwork by showing colour change on the indicator strip so the duration oftime the temperature exceeds a set threshold can be estimated. Examplesof dual time-temperature indicators are WarmMark and MonitorMark.Freeze indicators have colour bulbs that release a dye at the thresholdtemperature at or below Oe. There are different models available inAustralia from a variety of manufacturers: Freeze Watch,ColdMark.In Australia models that activate at OCare recommended.Combined Indicators: Stop!Watch: this monitor combines a dual time-temperature indicator (MonitorMark) with a freeze indicator (FreezeWatchactivated at OC).

- r " I -Dailyminimum/maximumtemperaturesstill need tobe r ecordedmanually as a I itimely alert toany breach inthe cold chain.

~!

-I n Aus tr aliafreezeindicatorsth at a ctiv ateat D o C arerecommended.

~ I

23


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- Store thediluents w ithth e v ac cin e.

- r " 'Keep IIrefrigerator!1doo r / c oo le rope~i~gs to aminimum,

2 4

r ' J .1.1

C A R IN G F O R Y O U R V A C C IN E S D U R IN GIM M U N IS A T IO N S E S S IO N S

K e y i s s u e s+ Do not use diluents warmer than the vaccine as they can affect the

potency oflive vaccines (e.g. using a diluent for reconstitution thatis warmer than a Ireeze-dried preparation, such as MMR, can affectthe potency of the vaccine).

+ Be aware oflight sensitive vaccines (most vaccines are sensitive toany form ofUV light including fluorescent light).

+ Keep refrigerator door/ cooler openings to a minimum.Vaccines are particularly vulnerable at the time of use because vials andampoules have to be opened, Ireeze-dried vaccines have to be reconstituted,and staff must handle many types of vaccines with different requirements.

During imm unisa tion o f g roups a t the clin ico r p ra ctic e

+ Take vaccine (and diluent if needed) from the cooler only asrequired. Reconstitute vaccines immediately prior to administering.

+ Administer the vaccine and dispose of used injection equipment inthe sharps container immediately.

+ Always shake the vaccine in the vial or ampoule briskly to mix thecontents just before administration in order to reduce risk oflocalreactions. Check the contents for clarity.

+ When the vaccines are outside the vaccine carrier, keep them out ofdirect sunlight and away from other sources of heat and ultravioletlight (e.g. fluorescent light).

+ Avoid handling vaccines any more than absolutely necessary.

Ou tre ach immun isa tio n se ss io ns+ Place new, unfrozen ice packs/gel packs in the freezer so they will be

ready for the next working day.+ Plan the session carefully. Ensure you take a sufficient stock of

vaccine, diluent, adrenaline and ice packs.+ If doing immunisation sessions outdoors, choose a cool shaded site.+ For a mobile service where there is no electric power supply or

refrigerator, take an extra cold box containing extra ice packs/gelpacks to replace the melted ice packs/gel packs.

If your circumstances require the use of a specialised vaccine cold box see'Specialised Vaccine Cold Box' p 35.


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U sin g MMR a nd o ther fre eze-d ried va ccin es w ith d ilue nt,d urin g a n immu nis atio n s es sio n:

+ Diluents may appear to be water, but usually contain a variety ofchemicals and additives specifically designed for the needs of eachvaccine, and therefore, are not interchangeable.

+ Use only the diluent supplied by the vaccine manufacturer for usewith that vaccine.

+ Make sure that the diluent is as cool as the vaccine. Do not freezethe diluent. Diluents need to be the same temperature as thevaccine at the time of reconstitution.

+ Use the entire volume of the cooled diluent supplied whenreconstituting the vaccine.

+ Reconstituted vaccine is very unstable and quickly loses potencyat room temperature after reconstitution. Reconstituted vaccinesshould be used within one hour (30 minutes for Varicella),providing they have been kept between +2C to +8C andprotected from sunlight and fluorescent light. However,reconstituted MMR can be stored in the plastic syringe in a darkplace between +2C to +8C without loss of potency for up toeight hours but then must be discarded if not used.

Check storage rules for other reconstituted vaccines like varicella-zostervaccine, some types of Hib vaccines and some travel vaccines as theguidelines differ slightly.Source: NHMRC (2003), page 184; WHO, UNICEF, BASICS/USAID (1998)WHO/EPI/LHIS/98.02.

IN V O L V IN G P E O P L E IN C O L D C H A INIf a person purchases a vaccine the safest cold chain procedure is to advisethem to get it from the pharmacist immediately before attending the GP. Ifthis is not possible, make them aware of the risks of freezing and warmingthe vaccine and advise them on safe storage procedures. An alternativeis for people to leave the vaccine with the Gp, clearly labelled with theperson's name and when it will be used.

I'I f a person is

Ipurcha~inga vaccm eth e sa t~ stco ld ca inprocedure is toadvise them toc ollec t it fr omthe pharmac is timmediatelybeforeattendingth e GP fo rvaccination.

' " l ! ~

2 S


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- [ 1 -Always have I Ian a lt erna tiv emeans ofvaccine s to rageavailable.

Dependingo n th e qua lityand design ofy our p ur po se~buil t vacc inerefrigerator,it may warmquic kly dur inga p ower fa ilu re.Do you needto add 'coldm ass' (e.g .c oo le d wa te rb ottles ) to y ou rrefrigerator?

2 6

1

I II

,

M A N A G E M E N T O F C O L D C H A IN P R O B L E M S

Powe r fa ilu reDomestic refrigerator

+ During a power failure of 4 hours or less the refrigerator doorshould be kept closed.

+ For power failures more than 4 hours store your vaccines in a coolerwith conditioned ice packs/gel packs (see 'How to pack a cooler'p 29- 30). Continue to monitor the temperature of the vaccines byplacing the thermometer probe inside a vaccine box inside the cooler.

Purpose-built vaccine refrigerator+ Monitor the temperature of your refrigerator. If vaccines are at risk

use alternative storage arrangements (some refrigerators may nothold the temperature very long).

Cold cha in b rea chL Immediately isolate the vaccines until you have been in touch with

the relevant state or territory health department (see p 53).2. Keep vaccines refrigerated between + 2C and +8C and label

'do not use:3. Do not discard any vaccine until advice has been sought from your

relevant state or territory health department.4. Contact your relevant state or territory health department as soon as

possible (in business hours).5. Take active steps to correct and prevent the problem recurring.6. For privately purchased vaccines contact the manufacturer for advice.

The following information will assist with rapid decision making about asuspected cold chain breach when you contact your state or territory healthdepartment:

+ Date of the breach.+ Do you store your vaccines in a domestic or purpose-built vaccine

refrigeratori'+ Minimum and maximum temperature readingi'+ Are Cold Chain Monitors (CCMs) stored with the vaccines? If'yes;

be ready to report the reading when breach was noticed.+ When was the thermometer last reset?


34/61

+ When was the thermometer battery last changedi'+ When was the last check on the accuracy of the thermometer done?+ How long do you think the temperature was outside +2C to +8Ci'+ How long do you think these problems have been occurringi'+ Where is the temperature probe situated?+ Where are your vaccines stored in the refrigeratori'+ What type and number of vaccines are in your current stock?+ What is the expiry date of your vaccines?+ Have vaccines been pushed up against the cooling plate or a cold

air outlet?+ Are the vaccines in their packagingi'+ If a domestic refrigerator-are the vaccines in enclosed plastic

containers?+ Are there water bottles in the doors, unused shelves and drawers of

the refrigeratori'+ What do you think was the cause of the cold chain breach?+ Has the cause of the cold chain breach been rectified?+ Has anybody been vaccinated with potentially affected vaccines?

,I

Management ofa suspected colacha in brea ch: I so la te v ac cin eswithin therefrigerator; Do not usethem or destroythem; Conta ctyour state orte rr ito ry h ea lthdepartmentASAP (inbus in es s hour s) ;and

' l f r a cold chainr ea ch in vo lv esprivatelypurc~asedvaccinescontact theman;lacturerfor a vice .._ ,

~'

2 7


35/61

-C hoose thecorrect coo ler

for your needs.

- r"Always f! 1condition theice packs/gelpacks.

2 8

" " " " ,

C O O L E R SA cooler, also known by names such as Esky" or Willow, is a solid-walledinsulated container with a tight fitting lid with the temperature insidemaintained by ice packs or gel packs.Coolers are normally not adequate for the transport of vaccines forprolonged periods (more than 8 hours or extreme conditions) as theircold life is limited. In this circumstance a specialised cold box wouldbe recommended for storing and transporting vaccines (see section on'Specialised Vaccine Cold Box' p 35).

T ips fo r us ing coo lers+ Choose a cooler that will meet your needs.

Freezing episodes happen very easily in all coolers, usuallyin the first 2 hours after packing. The minimum size coolerrecommended for storing vaccines is lOLIf you are experiencing difficulty maintaining a stabletemperature and are using a polystyrene cooler, change to aplastic cooler which provides better insulation. If using a plasticcooler and you are unable to maintain a stable temperature,consider upgrading to a higher quality cooler with refrigeration~type insulation or a specialised cold box.

+ Experiment with your cooler to know how many ice packs/gel packsyou will need. This will depend on:

ambient temperaturetype and size of coolernumber of vaccinescooler capacitysize and type of ice packs/gel packs

+ Condition the ice packs/gel packs (see'How to condition ice packsand gel packs' p 32-33).

+ Insulate the vaccines so they do not come into contact with the icepacks/ gel packs which are at OCtemperature.

+ Monitor the temperature of the vaccines.+ Ensure the contents of the cooler are packed securely so they cannot

move around during transport.


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+ Keep cooler out of the direct sun.+ Remove vaccines from the cooler only as they are required.+ Check the temperature has remained within +2C to +8C prior to

administering the vaccine.

H ow to pack a coo lerOp tio n o n e: This option can be used for storing vaccines up to 8 hours (seeFigures 2 and 3 on the following pages).

+ Chill the inside of the cooler prior to use by placing ice packs/gelpacks in it for a few hours.

+ Place polystyrene chips, shredded paper or other suitable insulatingmaterial at the bottom of the container, this eliminates 'hot and coldspots: Packaging such as polystyrene chips is preferable to bubble-wrap which stops air from circulating near the vaccine. However ifusing bubble-wrap avoid wrapping the vaccines tightly.

+ Pack the freeze-sensirive vaccines in the centre of the container andthe Ireeze-tolerant vaccine closest to the ice packs/gel packs.

+ Place a minimum/maximum thermometer and a freeze indicator(or a dual time-temperature indicator if either is used in your stateor territory) in the centre of the vaccine stock.

+ Surround the vaccines with packing material which allows cold airto circulate.

+ Place the conditioned ice pack/gel pack( s) (see p 32- 33) on top,close and seal the lid of the cooler. If you are using a larger cooler,place conditioned ice packs/gel packs around the sides of the cooleras well as on top. You will need to experiment to find the correctcombination for your needs.

+ Ensure vaccine stock is not in direct contact with the ice packs / gelpacks to minimise risk of freezing.

+ Monitor the temperature before you leave,when you arrive, prior toadministering vaccine and regularly throughout the immunisationsession (at least hourly).

Danger: incorrect conditioning of ice packs/gel packs may causevaccines to freeze easily because incorrectly or unconditioned

ice packs/gel packs are too cold for safe vaccine storage.

- r ' I -Correctly [ Ipacking aicoo ler reducesthe risk ofj freezing.

I

-Pre~chill th ecoo ler bef oreuse. I

-Incorrectlyconditioned orunconditionedice packs/gelpacks are toocold for safevaccine s to rageand may e~silycause vaccinesto freeze.L

29


37/61

- rrFreezing1:1episodeshappen verneasily in a 1coolers, usua ll yin the first 2h ours a fter

J packing.- I-=

3 0

p,~'Iy$tyr'en;esheets:(' I ~ : ' 2 O m m ) . ' i o o l y s ~ y r r e l l 1 l e '< 1 1 ! 1 1 ) 5 .iir b l J ~ b l e ' wr~r;li

P,glysityrol;!n~ il;hips Jo r i tr ul !) . b le ' 1 f . I Y . a ( l ' F~~ l m ; l i l ; ; ' ? il i O F in wi~r ~ z . e - : ; ; e r u s . 1 ~ ~ VI1i!;


38/61

O p tio n tw o: Packing vaccines into a polystyrene container which is thenplaced into a larger cooler.

+ Choose a polystyrene container large enough for your needs andchill the inside of it by placing some ice packs/gel packs inside for afew hours.

+ Place vaccines, a minimum/ maximum thermometer and a freezeindicator (or a dual time-temperature indicator, if either is used in yourstate or territory) inside the polystyrene container and secure the lid.

+ Ensure the minimum/ maximum thermometer probe and freezeindicator are placed in the centre of the vaccine stock.

+ Pack the polystyrene container inside a large cooler and surround itwith ice packs/gel packs. Secure the lid.

+ Monitor the temperature before you leave, when you arrive, prior toadministering vaccine and regularly throughout the immunisationsession (at least hourly).

High quality coolers cost several hundred dollars and are availablefrom large boating, fishing or camping suppliers. They may have thickrefrigerator~grade insulation and fibreglass or plastic walls. Some may havesmall 'feet' so that the bottom of the cooler does not contact warm surfacessuch as the floor of the boot of the car. Check with the manufacturer aboutthe technical specifications and performance of the cooler.

Figure 4: Example of packing a polystyrene container inside a large cooler31


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- r .Ice packs and Igel packs mustbe co rrec tlyconditionedbefore use. Ther is k o f J : ee zingvaccinesincreases i fth e ice p ac b/gel packs arenot cor re ctl_ 'conditione .'

~

- r .I nc orrec t u ser lf gel packs isev en r is kie r

than icec:because t e gelpa ck s rem ainc old er th anD O C for longerthan ice packs.

.ii- " " ' ~ ' "

3 2

Freezing and cond ition ing o f ice packsand ge l packsIce packs are water-tilled and come out of the freezer at a temperatureof about -18C. It normally requires at least 12 hours in a freezer or 24hours in a freezing compartment of a domestic refrigerator for an ice packto be frozen and brought down to the temperature in the freezer (which issignificantly lower than the freezing point of the ice pack). Achieving thelower temperature will provide a longer 'cold life' for the ice pack.There are a number of different types of gel packs that contain chemicalsthat depress the melting point and ensure the gel remains colderthan OC for longer than water-tilled ice packs. There is an increasingrange of gel and phase-change materials becoming available that arealso used to maintain the temperature of coolers. They tend to havefreezing points below OC and present a risk of freezing vaccines unlessthey are appropriately conditioned for use in the cooler or cold box.Before purchasing gel packs, request current documentation from themanufacturer that:

1. Validates their claims about the product's cold life.11. Provides clear instructions on how to freeze and condition the

product before use, and how to safely pack a cooler with the gel packand vaccine.

Gel packs will take longer than ice packs to freeze. Generally it will takearound 24 hours in a freezer and longer in a domestic refrigerator freezerto completely freeze gel packs.One of the greatest risks to vaccines from freezing occurs when they aretransported in a cooler or cold box and this risk increases if the ice packs/gel packs are not correctly 'conditioned:Conditioning is a term which refers to leaving the ice pack(s)/ gel pack(s)at room temperature to allow the ice or gel at the core to rise to about OC.This minimises the risk of damaging vaccines from freezing.


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H ow to cond ition ice packsCondition the ice packs as follows:

+ Remove ice packs from the freezer.+ Layout ice packs in single row on their sides (where possible)

leaving a Scm space around each ice pack to allow maximum airexposure to reduce the 'conditioning' time.

+ Wait until ice pack(s) begins to sweat. This will take up to one hourat +20C and a lot less at higher temperatures.

+ The ice pack is conditioned as soon as water begins to 'slosh' aboutslightly inside the ice pack.

H ow to cond ition gel packs+ Usually gel packs will take longer than ice packs to condition so that

they are safe to use for vaccine transport.+ Follow the manufacturer's instructions on correct conditioning of

the gel pack. There is no 'one rule fits all' approach to conditioning allthe available gel packs. However there are some industry standardsthat can be used to guide conditioning if gel packs have been storedin the freezer at -20C for a minimum of 36 hours.

+ Conditioning of frozen gel packs for the times prescribed in theTable on the next page enables the initial chill factor to be removedfrom the packs.

- r " J .G el packs will , Iusua lly ta kelo ng er th anice packs tocondition.I

33


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3 4

G uide to tim e needed to condition sm all and la rge gel packsGel packs weighing less than750gm

+ If ambient (room)temperature is over +15C,condition for 45 minutesbefore use.

+ If ambient temperature isless than +15C, conditionfor 1 hour before use.

Gel packs weighing more than750gm

+ If ambient (room) temperatureis over +15C,condition for1 hour beforeuse.

Examples of gel packs weighingless than 750gm

+ If ambient temperature isless than +15C, conditionfor I1h hours before use.

Examples of gel packs weighingmore than 750gm


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S p ec ia lised vacc in e co ld bo xA cold box is a purpose-built product. It has thick walls and is significantlymore expensive than a cooler.Insulation thickness of the cold box should be at least 30mm thick and,if possible, 80mm thick in the walls and lid. Fibreglass cold boxes with50mm refrigeration grade insulation are available.For longer term storage or extreme conditions (storage environment is< o o e or >40o e or) a specialised cold box is needed.rLonger term' generallyrefers to more than 8 hours (one working day). Specialised cold boxes areavailable that meet WHO recommendations. A large cold box should havea minimum cold life of 120 hours at an air temperature of 43C withoutopenings. Specialised vaccine cold boxes need to be imported.WHO has a list of specifications at:http:// www.who.int/ vaccines-access/ vacman/ pis/ e04.pdf and productinformation sheets at http://www.who.int/vaccines~documents/DocsPDFOO/www518.pdfFor more information on specialised vaccine cold boxes refer to the'Proceedings of the National Vaccine Storage Workshop' (p 79) availableon website http://immunise.health.gov.au/vaccinestorage.htm

Po rtab le re fr ig e ra to rsPortable refrigerators have a high propensity to freeze vaccines and shouldnot be used unless they have been rigorously appraised (e.g. their controlscannot be inadvertently changed; a correct temperature can be set and willbe maintained throughout the vaccine storage areas). If transporting vaccinesfor three days or more you need to use a specialised vaccine cold box.

3 S
http://www.who.int/http://immunise.health.gov.au/vaccinestorage.htmhttp://immunise.health.gov.au/vaccinestorage.htmhttp://www.who.int/


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3 6

A P P E N D IX 1V A C C IN E S T O R A G E S E L F A U D ITSelf-auditing is important because:

+ It is part of routine quality assurance and risk managementprocesses.

+ It enables you to have confidence that you are providing a safe andeffective vaccine.

You can photocopy these pages and keep as a record of an audit. It issuggested that auditing is done at least every 12 months.Date of self audit / /Person conducting Audit:

P R O C E D U R E S

C heck lis t fo r sa fe vaccin e ha nd lin g an dsto rag e w hen using a d om estic re frig era to ro r a purpose - b uilt refr igeratorHave all staff received training to enable them to possess Y Nadequate knowledge in performing their role in cold chainproceduresi'Is a record available that shows monitoring of the Y Ntemperatures at the beginning of each working dayi'(before the vaccine is used)Is a record available that shows monitoring of the Y Ntemperatures at the end of each working day (minimumrequirement is daily prior to commencing vaccination)i'Is there a valid documented reason if monitoring has Y N N / Abeen missed?Were all deviations outside +2C and +8C reported to Y N N / Athe appropriate state or territory health departmenti'Have the responses to all deviations outside +2C and Y N N / A+8C been documented and recommended actions taken?


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EQUIPMENTDomes t ic r efr ige ra to r sWhen was the battery for the thermometer( s)/ datalogger( s) changedi'

/ /

Date and the results of checking the accuracy of yourthermometer (do at least 12 monthly) (see 'How to checkthe accuracy of your thermometer' p 22)i '

/ /

If a cyclic defrost refrigerator, when was the refrigeratorlast defrosted?

/ /

Has the refrigerator shown evidence of malfunction (e.g.poor seals so that the door opens too easily, ice build up) i'If'Yes, what action was taken?

Y N

Is the temperature probe placed correctly as recommended(see Step 10 p 14)i'

Y N

Is there an appropriate gap between the vaccines and thewalls, element, air outlets and a buffer (if necessary) in placei' Y N

Are the vaccines stored in enclosed plastic containersprepared according to these guidelines (see Step 7 p 12)i '

Y N

Can the refrigerator continue to store the volume of vaccinessafely according to these guidelines (this includes times ofincreased demand e.g. influenza program)i'IfNo, what action are you takingi'

Y N

Are there enough water bottles and/ or ice packs/gel packsin the shelves of the door, lower drawer and empty shelves?

Y N

3 7


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3 8

Pu rpose -bu ilt v acc ine re frig e ra to rsHas the refrigerator shown evidence of malfunction(e.g. poor seals so that the door opens too easily)?

Y N

Is there an appropriate gap between the vaccines andthe walls? Y N

If using a thermometer or data logger, when was thebattery changed?

/ /

Can the refrigerator continue to store the volume of vaccinessafely according to these guidelines? (This includes times ofincreased demand e.g. influenza program).If'No, what action are you taking?

Y N

A lte rn ative va cc in e s to ra geIs there an alternative (e.g. cooler, other monitoredrefrigerator) available for vaccine storage, if necessary(e.g. vaccine refrigerator breakdown)?

Y N

Are ice packs/gel packs at the correct temperature available? N


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APPE NDIX 2Common m isco nceptio ns a bo ut va cc in esto ra ge m a na geme nt1. Myth: Vaccines are robust products that tolerate heat and cold.

Fact: Most vaccines are considered damaged with temperatures ofOCor below. Some vaccines are sensitive to high temperatures.Generally the lower temperatures are more dangerous to vaccinepotency than slightly high temperatures.

2. Myth: Vaccines are free (or cheap).Fact: Vaccines range in price from a few dollars (e.g. tetanus) toabout $180 (e.g. privately purchased conjugate pneumococcalvaccine). Even a small general practice can be storing vaccinesworth about $4,000.

3. Myth: Warming of vaccines is more harmful than freezing.Fact: In Australia, most vaccines are destroyed by freezing.There are some vaccines that are particularly heat sensitivee.g. reconstituted MMR.

4. Myth: Vaccines that have been frozen look frozen, solidor changed.Fact: Most vaccines do not appear different even when they havebeen frozen. At cold temperatures that would damage the vaccine,they may not appear 'frozen' and can be easily drawn up.

5. Myth: Vaccine refrigerators look after themselves. Domesticrefrigerators storing vaccine require a low level of care.Fact: Domestic refrigerators are designed for food storage and arenot designed to meet the specialised needs of vaccines and placethe safety of vaccines at risk. Careful monitoring and knowledge ofyour refrigerator is required to minimise risk to the vaccine.

6. Myth: Cold chain management is someone else's responsibility.Fact: All people handling vaccines are responsible for maintainingthe cold chain. It is recommended that a key person is nominatedto oversee vaccine management.

7. Myth: If the thermometer shows a temperature outside +2C to+ 8C, there must be something wrong with the thermometer.Fact: If refrigerator temperatures are outside the recommendedrange, the thermometer reading should be assumed to be correctuntil proven otherwise. Always take action to report it straight away.

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4 0

8. Myth: Temperature monitoring equipment and some thermostatoverride devices eliminate the need for staff intervention andmonitoring of the cold chain.Fact: Temperature monitoring equipment and thermostat overridedevicesdo not guarantee safety of vaccinesand should not beconsidered a substitute for good vaccinestorage management.

9. Myth: The temperature throughout the refrigerator is the same.Fact: Temperatures vary throughout the refrigerator, between theshelvesand evenon the same shelf.

10. Myth: If the temperature increases in the refrigerator for anyreason, you should alter the thermostat dial for a short timeuntil the required temperature is reached.Fact: If you have cooledwater bottles (for 'coldmass') and anadequately functioning refrigerator the refrigerator should revertto the normal operating temperature fairly quickly.Haphazardchanging of the dial can destabilise the temperature and put thevaccinesat risk.

11. Myth: Refrigerators cannot get to freezing.Fact: Domestic refrigerators can drop to temperatures belowo o e depending on the location within the refrigerator (e.g.near the cooling plate or cold air outlets) and the temperaturecontrol settings.


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APPE NDIX 3Case stu dyThis GP works in a busy four doctor medical centre in an innermetropolitan area. The refrigerator used to store vaccines in the practiceis a domestic Irost-Iree refrigerator which had been difficult to stabilisebetween the required +2C to +8C range despite being a'modern'electronic model. Before modification the refrigerator temperatures variedbetween + 1C and +100e.After attending the National Vaccine Storage Workshop inJune 2004 asthe RACGP representative, the GP went through the following steps:

+ Initial monitoring of the refrigerator to get to know it:+ Assessed that the best place for freeze sensitive vaccines was away

from the air vents at the back of the refrigerator.+ Placed maximum number of cooled water bottles in the shelves

in the refrigerator door to add 'cold mass' and assist in stabilisingrefrigerator temperatures.

+ Placed ice packs (on their side with a gap between each) inthe freezer.

+ Purchased a set of enclosed plastic drawers to store vaccines. Ineach drawer placed a gel pack at the back to act as a buffer againstcold air vents and assist in stabilising temperatures in those drawerscontaining fewer vaccines.

+ Labelled each drawer with the contents.+ Confirmed temperatures by monitoring with two thermometers

with probes placed at varying places within the refrigerator. Thetemperatures have also been confirmed by data logging. Sincemodification, the refrigerator temperatures have remained within a4C to 6C range.

Total cost of equipment for modification was $160.00. Equipmentwas purchased from a large department store. Similar equipment isreadily available.

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4 2

Figure 1: Refrigerator after monitoring and modification+ Vaccines stacked in plastic boxes eachwith separate drawers.

Drawers are labelled for easy identification of vaccine required.+ Air circulation possible between stacks and into front of containers.+ The rear of each container is sealed.+ Warning sticker over the thermostat.

Note: there aremedications, not vaccinesor diluents in the drawer at thebottom of the refrigerator.

Figure 2: Water bottles in refrigerator doorDoor filledwith bottles of water to provide 'coldmass' and to reducetemperature loss on opening the refrigerator.


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Figure 3: Packing of freezer+ If you need the ice packs/gel packs to freeze quickly ensure there is a

space between them to allow cold air circulation.+ Ice packs and gel packs can be placed in the door of the freezer but

these packs will take longer to freeze completely.+ Storing ice packs/gel packs in the freezer will assist in stabilising the

temperature in your refrigerator compartment as in most Irost-Ireerefrigerators cold air is distributed from the freezer to the fresh foodcompartment.

Figure 4. Vaccines packed in a pull out drawer (enclosed plastic container)+ Vaccines stacked in their original boxes to preserve temperature

buffer. Labelled drawers slide out for easy selection.+ Vaccine boxes clearly marked with expiry date.+ Temperature probe placed within a vaccine box placed at the back of

the drawer.+ Gel pack fixed to back of the container. This provides some

temperature stability as well as protection (a buffer) from cold airvents at back of refrigerator unit.

+ Individual pull out drawers can be removed from the refrigerator forrestocking to minimise door opening time.4 3


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A P P E N D IX 4

H O W T O ID E N T IF Y A N D M A N A G E S IT U A T IO N SW H E N T H IN G S G O W R O N GReport all variations outside +2C and +8C to the relevant state orterritory health department unless:

+ Short term elevated temperatures from opening the door duringroutine use or unpacking a new vaccine order.

Copin g w ith y our d om e stic re frig era to rThese are a fewexamples of what can go wrong!

Issue:Youhave a cyclicdefrost refrigerator where there is a cooling plate or afrost free refrigerator with cold air outletts). This places the vaccines incloseproximity at risk of freezing.Po ten tia l s o lu tion :Store your vaccines in a enclosed plastic container with a strip ofpolystyrene at least 12mm to 20mm thick glued to the area of thecontainer at risk of having the greatest exposure to cold temperaturefrom the cooling plate or the cold air outlet.

Do no t use g la ss o r m eta l co nta iners a s th eyp ro vi de le ss buf fe rin g t o temperat ur e d ev ia ti on s.

Issue:Refrigerator temperatures can become unstable if there is a smallvolume of vaccines stored in the refrigerator or there is a power failure.Refrigerator contents need to have sufficient'coldmass' to assist inmaintaining stable temperatures. This applies to domestic and purpose~built vaccine refrigerators.Po ten tia l s o lu tion :Store cooled water bottles in the empty areas of your refrigerator e.g.refrigerator door, any empty shelves and the lower drawers to stabilisethe temperature. Water bottles increase the 'coldmass' in the refrigerator.When p la cin g mor e w ater b ottles in th e r ef rig er ato r en su re th ey a re filledw it h c oo l wa ter t o a vo id d es ta bi li sin g th e v ac ci ne r ef ri ge ra to r e nv ir onmen t.Moni to r t he r ef ri ge ra to r t emperat ur es c lo se ly unt il t he y hav e s ta bili se d.


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Issues:+ Small volume of vaccines+ Difficulty stabilising the refrigerator temperature

Po ten tia l s o lu tion :Store your vaccines in an enclosed polystyrene box within therefrigerator and place the thermometer probe inside a vaccine package,inside the polystyrene box. Increase the 'cold mass' of refrigeratorcontents (se

strive 4 five

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